Colorectal Cancer MetastaticPhase 3NCT02149784
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients
A Phase 3 study testing Surgical resection of primary tumor in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.
Trial summary
There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Surgical resection of primary tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old
- both genders
- ECOG:0-2 score
- Pathological confirmed colon cancer or rectal cancer with at least 12 cm far away from anal verge
- CT,MRI,or PET-CT confirmed metastasis
- MDT confirmed unresectable metastasis lesion
Show all 11Show fewer
- No evidence of obstruction, bleeding, perforation
- WBC≥4.0×109/L，Neu ≥2.0×109/L，PLT≥100×109/L
- No contraindication for chemotherapy
- No evidence of other malignant tumor
- Expected survival time > 6 months
Who cannot join
- mCRC patients who did not respond to first line chemotherapy
- Require surgical intervention during the primary tumor-related symptoms
- Obvious coagulopathy
- Severe heart, liver, kidney damage or other serious uncontrolled medical illness or acute infection, cachexia
- Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
- Pregnant or lactating women or women of childbearing age who refuse to accept contraception.
- Nearly three months participated in clinical trials of other persons.
- Mental abnormalities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Gong Chen, Prof., +86 20 87343584, chengong@sysucc.org.cn
Gong Chen, Prof.
About this study
Official title: Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study
There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Surgical resection of primary tumor
- Keywords
- Metastasis colorectal cancer, Chemotherapy, Resection of primary tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resection of primary tumorProcedure or surgery
Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment group | Experimental | Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor. Receives: Procedure: Surgical resection of primary tumor |
| Chemotherapy group | No intervention | Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (1)
Number of Participants with Adverse Events both in surgery group and chemotherapy group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Chen, Sun Yat-sen University
- Investigators
- Gong Chen, Prof., Principal investigator, Sun Yat-Sen University Cancer CenterZhi-zhong Pan, Prof., Study chair, Sun Yat-Sen University Cancer CenterDe-Sen Wan, Prof., Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149784
- Sponsor's protocol ID
- 20140413
- Status last verified
- Apr 2017
- First submitted
- 18 May 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02149784
- Acronym / sponsor ID
- 20140413
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Metastasis colorectal cancer, Chemotherapy, Resection of primary tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment group | Experimental | Procedure: Surgical resection of primary tumorUnresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor. |
| Chemotherapy group | No intervention | –Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 70 years old
- both genders
- ECOG:0-2 score
- Pathological confirmed colon cancer or rectal cancer with at least 12 cm far away from anal verge
- CT,MRI,or PET-CT confirmed metastasis
Key exclusion criteria (8 listed)
- mCRC patients who did not respond to first line chemotherapy
- Require surgical intervention during the primary tumor-related symptoms
- Obvious coagulopathy
- Severe heart, liver, kidney damage or other serious uncontrolled medical illness or acute infection, cachexia
- Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resection of primary tumorSurgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy' | Procedure or surgery | Surgical treatment group |
Primary outcome
Overall survival
Time frame: 3 years
1 secondary outcome
Number of Participants with Adverse Events both in surgery group and chemotherapy group
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gong Chen, Prof. principal investigator
Sun Yat-Sen University Cancer Center
Zhi-zhong Pan, Prof. study chair
Sun Yat-Sen University Cancer Center
De-Sen Wan, Prof. study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgical resection of primary tumor in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gong Chen, Prof. (+86 20 87343584, Chengong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.